January 2018
Investor Presentation January 2018 D i s c l a i m e r This - - PowerPoint PPT Presentation
Investor Presentation January 2018 D i s c l a i m e r This - - PowerPoint PPT Presentation
Investor Presentation January 2018 D i s c l a i m e r This confidential document and the information contained in this document (the Presentation ) constitutes neither an offer for sale or subscription nor a solicitation of a purchase or
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D i s c l a i m e r
This confidential document and the information contained in this document (the “Presentation”) constitutes neither an offer for sale or subscription nor a solicitation of a purchase or subscription order for Cellnovo shares in any country. No offer of shares is made, or will be made in France, before obtaining a visa from the Autorité des Marchés Financiers (the “AMF”) on a prospectus comprising a registration statement (document de base) and securities note (note d’opération) that will be submitted to the AMF. In particular, this Presentation does not constitute an offer for sale of securities or any solicitation of a purchase or subscription order for securities in the United States or by U.S. persons (as such terms are defined in Regulation S under the U.S. Securities Act of 1933, as amended (the “Securities Act”). Cellnovo shares may be only offered or sold in the United States pursuant to an effective registration statement under the Securities Act or under an exemption from the registration requirement of the Securities Act. Cellnovo shares have not been and will not be registered under the Securities Act, and Cellnovo has no intention of making any public offering of its shares in the United States. This Presentation does not constitute a prospectus within the meaning of Directive 2003/71/EC of the European Parliament and of the Council of November 4, 2003, as amended, in particular by Directive 2010/73/EC of the European Parliament and of the Council of November 24, 2010 (the “Prospectus Directive”). Its dissemination may be governed by specific regulations in certain countries. Persons in possession of this Presentation should therefore acquaint themselves and comply with any local restrictions. No action has been taken or will be taken for the purpose of enabling a public offering of securities requiring the publication by Cellnovo of a prospectus in a Member State other than France. Consequently, the Cellnovo shares may not and will not be offered in any Member State other than France, except in accordance with the exceptions set forth in Article 3.2 of the Prospectus Directive or in other cases not requiring publication by the Company of a prospectus pursuant to Article 3.2 of the Prospectus Directive or other applicable regulations in that Member State. Regarding the United Kingdom, this Presentation has not been approved by an authorised person in accordance with Section 21 of the Financial Services and Markets Act 2000 and therefore it is intended to be delivered solely and for information purposes only to persons who (i) are investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as currently in effect, hereinafter the “Financial Promotion Order”), (ii) are referred to at Article 49(2) (a) to (d) (“high net worth companies, unincorporated associations, etc.”) of the Financial Promotion Order, (iii) are outside the United Kingdom, or (iv) are persons to whom an Presentation or incitement to engage in investment activities (within the meaning of section 21 of the Financial Services and Markets Act 2000) in the context of the issuance or disposal of securities may legally be extended, directly or indirectly (all such persons being collectively named “Authorised Persons”). This Presentation may not be used by any person who is not an Authorised Person. By accepting this Presentation and not immediately returning it, the recipient represents and warrants that they are a person who falls within the above description of persons entitled to receive the Presentation.
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A M a n a g e m e n t Te a m W i t h A S u c c e s s f u l Tr a c k R e c o r d
- Dr. Sophie Baratte
CEO
20 years of experience in Sales & Marketing functions in the medical technology sector, including Sorin Group
Served as CEO of CIT, General Manager for the In Vitro Diagnostics branch of Johnson & Johnson in France and as senior EMEA Sales & Marketing Director for Lifecell Engineer, Ph.D. in biotechnology, MBA
Erwan Martin CFO
20 years of experience in finance and biotechnologies
Former CFO of Genomic Vision, co-founded Cytomics Pharmaceuticals, served as project manager at Syndex
- Dr. Julian Shapley
CSO, Founder
NASA experience
Founded Cellnovo in 2008 MBA at Warwick Business School Ph.D. in micro-fluidics at Cardiff University
John Brooks Chairman
Served as CEO and Founder of Insulet, and as CEO of Joslin Diabetes Center
Over 30 years of experience in the medical device industry in diabetes
Javaid Masoud CTO
Served at Medtronic and at Sorin Group in Senior director roles for wireless technologies, embedded firmware development for implantable cardiac defibrillators, wireless communication protocol, embedded firmware for implantable devices, and software for external instruments
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C e l l n o v o i n a N u t s h e l l
The first connected, all-in-one Diabetes Management System
- 1. North America+ Main European countries, Medtronic's, Investor Conference, June 2014
- Cellnovo develops and commercialises a disruptive insulin micro-pump
- A $2.5Bn market: Growing and well-reimbursed
Focused on Type 1 diabetes with a potential for larger Type 2 market
- Addressing clear market needs
The only real-time data device, for better patient outcomes
- Unique accuracy and safety features
- A clearly defined global strategy supported by strategic partners
- Roche: Contract for Blood Glucose Measurement
- Flex: Manufacturing partner
- Air Liquide: Major distribution partner
- Road map towards Artificial Pancreas and smartphone
- IPO on Euronext Paris in July 2015
- €20m loan agreement with the EIB – July 2017
- €17.5m capital raise from healthcare investors – July 2017
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Ty p e 1 D i a b e t e s : A l a r g e m a r k e t , w e l c o m i n g i n n o v a t i o n
T1 Patient Market* MDI Tubed Pump Micro-Pump US % Patient Use
70% 26% 4%
EU % Patient Use
85% 12% 3%
Market Size
$2 B $400 M
Growth Rate
<5% 40%
Market Players
Pumps are providing short and long-term benefits to patients, despite low penetration
* Source: Company estimates
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C e l l n o v o : A G a m e C h a n g e r f o r I n s u l i n P u m p Te c h n o l o g y
The perfect combination between a new generation of micro-pump and a mobile handset to allow the best accuracy and a 24/7 health remote monitoring Intuitive operation, wireless connectivity, real-time tracking, and Bluetooth and Android-enabled = All industry firsts
- The insulin reservoir
- Pumping mechanism
- Occlusion sensor
- High resolution, full-colour touchscreen
- GSM Modem
- Micro SD port
- Apps-friendly
- Roche BG Meter integrated
- Bolus calculator
- Real-time data
- Automated capture of data
and transmission
- Analytics and trends
- Stakeholders access
- Pump microprocessors and
memory
- Rechargeable battery
- Accelerometer
- Precision reservoir sensor
Insulin Cartridge Mobile Handset Online Wireless Durables Disposables
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- Informing payers of compliance to
treatment
- Lower pricing compared to other
micro-pumps
C e l l n o v o , a B r e a k t h r o u g h i n I n s u l i n D e l i v e r y, f o r a l l S t a k e h o l d e r s Driving Savings
- Ideal pump for lifestyle,
wearability, comfort
- High demand from patients
- E-connected for family’s peace of
mind
- Interoperability with connected
devices (CGM, BGM, activity trackers, e-watches)
- Real time information to drive better
patient outcomes
- Unrivalled accuracy and safety of
drug delivery in micro-pumps
Cost Effective Patients’ support
- Effective patients’ communication and trouble shooting,
based on real time back-end data
Freedom and peace of mind
The only e-connected, accurate, wearable insulin micro-pump
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C e l l n o v o , t h e F i r s t C o n n e c t e d M i c r o - P u m p A l l o w i n g M a x i m u m I n t e r o p e r a b i l i t y i n t h e D i a b e t e s E c o s y s t e m
ALGORITHMS CONTINUOUS GLUCOSE MONITORS FOOD LIBRARIES WEARABLES, HEALTH MONITORS BLOOD GLUCOSE METERS
Other Dataflows Cellnovo Dataflow
Dexcom PATIENT
Agenda
1. A unique technology 2. A company well-placed on COGS 3. An aggressive commercial strategy 4. The next breakthrough: The Artificial Pancreas 5. Financials
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C e l l n o v o B e n e f i t s C o m p a r e s P o s i t i v e l y t o t h e o t h e r M i c r o - p u m p s
For additional comfort Better outcomes and peace of mind Better COGS and eco-friendly device High quality of treatment A key feature for all Intuitive usage Bluetooth and Android-enabled
E-health in real time Higher accuracy of delivery Disposable plastics Detachable Enhanced safety Touchscreen colour Handset
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T h e C e l l n o v o S y s t e m : T h e M o s t A c c u r a t e M i c r o - p u m p i n D r u g D e l i v e r y
Not all micro-pumps are equal
Cellnovo: 2-part pumping system
- 100,0%
- 50,0%
0,0% 50,0% 100,0% 50 100 150 200 Flow rate error Observation duration (minutes)
Omnipod
Percentage error vs. observation window (Time based).
- 100,0%
- 80,0%
- 60,0%
- 40,0%
- 20,0%
0,0% 20,0% 40,0% 60,0% 80,0% 100,0% 50 100 150 200 Flow rate error Observation duration (minutes)
Cellnovo
Percentage error vs. observation window (Time based).
Cardiff University, UK- Jenna L Bowen and Chris J Allender - Trumpet curves for a typical Cellnovo and OmniPod™ patch pump device showing the maximum positive and maximum negative flow rate error (green solid lines) and the average flow rate error (red dotted line) for 2, 5, 11, 19 and 31 pulses.
- Accuracy of the wax-powered
pumping mechanism
- Superiority of durable electronics
and drop-by-drop alterations control system
A difference explained by the design
Traditional micro-pump: Fully disposable, all-in-one system
- Low cost, low
sophistication electronics
- Flat rate pumping
mechanism
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A c c u r a c y, t h e R e s u l t o f a U n i q u e M e c h a n i s m o f D e l i v e r y
The core technology: The paraffin wax micro-actuator
The expansion of heated paraffin wax serves as a mechanism to push a piston against a membrane, thereby creating a pumping mechanism OCCLUSION VALVE INLET VALVE OUTLET VALVE PUMPING CHAMBER GEARING PISTON DIODE
WAX
Cool Wax Heated Wax
After melting
+15%
Volumetric Expansion (%) Solid phase Liquid phase
IP protected until 2035
Wax Micro Actuator Displacement Sensor Micro- Valve Cyber security
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S a f e t y S y s t e m s O n B o a r d
Product Time to Occlusion Alarm Missed Insulin (U) Cellnovo 24.12 2.02 Omnipod Gen2 41.35 3.46 Medtronic 57.49 4.82 Animas Vibe 44.09 3.68 Roche Spirit Combo 28.47 2.39
Best-in-class in case of occlusion
Intelligent Delivery System
Delivery Sensor
Automatic release mechanism Temperature risk alarm
Insulin delivery alarms
72-hour Expiry alarm
Encryption
The pump’s electronics, designed to bring safety to a new level
Agenda
1. A unique technology 2. A company well-placed on COGS 3. An aggressive commercial strategy 4. The next breakthrough: The Artificial Pancreas 5. Financials
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C o n s u m a b l e s : L a r g e - s c a l e P r o d u c t i o n w i t h F l e x
- High volume automation and
manufacturing
- Stacked basic components,
suitable for high cavity moulding
Flextronics’ mass production Cellnovo’s limited production Ongoing transfer from Cellnovo to Flex
IC capacity
Per production line
Capacity pa
600,000
IC capacity Capacity pa
50,000
From Cellnovo’s R&D workshop To Flex Austria Followed by production in Romania Design to cost to further optimise COGS
1 2 3 4 1 2 3 4
Increasing volumes of consumable parts Reducing COGS
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D u r a b l e E l e m e n t s : A s i m p l e p r o d u c t i o n r o a d m a p
The mid-term manufacturing strategy favours outsourcing Cellnovo to remain lean with low overheads
Relatively low production volumes are required: Each patient needs 2 pumps and 1 handset The manufacturing roadmap will aim at decreasing COGS by 2-fold
2018 : Replaced by a smartphone Assembled by Cellnovo
Production strategy
2017: Assembled by Cellnovo
- PCB made by Sony
The Micro-Pump The Handset
2019: Outsourced
*
* Picture non-contractual
- PCB made by Sony
Agenda
1. A unique technology 2. A company well-placed on COGS 3. An aggressive commercial strategy 4. The next breakthrough: The Artificial Pancreas 5. Financials
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E a s y t o A c c e s s w i t h F a v o u r a b l e R e i m b u r s e m e n t
Cellnovo micro-pump has access to public funding across many geographies
Market Durables 3 Day disposables
USA $4,500 $15 UK £2,750 £11.30 France €2,340 €16.65 Italy €4,800 €18 Germany €2,800 €12
- 1. Source : Company
Simple market access based on existing codes
- Market access provided by CE marking
- Already CE marked
- Market access provided by 510K clearance
- Expected in 2018
- Reimbursement using traditional pumps’ codes
- Established codes in each countries
- Describing a durable pump and a consumable
part
- Reimbursement using CPT code 1
Tube pumps’ prices
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C e l l n o v o ’ s C o m m e r c i a l R o a d M a p
A network with direct sales forces and experienced distributors
2014
System introduction through proprietary sales force in the UK and France
2016
Expansion into other major European countries using specialized distributors : The Netherlands, Italy
2017
Expansion into Spain, Ireland, Greece, Israel, ..
2016
510k submission
2018/2019
Launch in the US Launch in Canada First countries in Latin America
2017 Launch in Australia/NZ 2018 Launch in Hong Kong 2019/2020
Launch in India Launch in China
Europe USA China/Asia
Direct Distribution (UK, France) Air Liquide Santé network: Benelux, Italy Expansion to new European countries
Agenda
1. A unique technology 2. A company well-placed on COGS 3. An aggressive commercial strategy 4. The next breakthrough: The Artificial Pancreas 5. Financials
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C e l l n o v o , t h e S y s t e m o f C h o i c e f o r A r t i f i c i a l P a n c r e a s
- US well-proven
program, with 215,501 hours of clinical trial
- Continuous work with three partners to reach
strategic objectives:
- Best in class AP system on a wearable
pump
- Recognised manufacturer of the
system
- Maximise business value for the
Company
All projects with Dexcom G5
- French atomic center
mathematicians and 12 major teaching hospitals in France
CONT INUOUS GL UCOSE SE NSOR CONT R OL AL GOR IT HM- Automatic adjustments of insulin
delivery
- Based on expert software and
Continuous Blood Glucose reading
- Un-Equaled Quality of Life
- Less Deadly Complications
The potential to be the #1 Artificial Pancreas using a micro-pump
Artificial Pancreas, the next breakthrough in diabetes management Cellnovo‘s partners Commercial strategy
- European consortium of
leading UK and European universities and companies
- n artificial intelligence
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R & D R o a d m a p
A steady flow of continuous updates and developments
2016 Roche BGM PEPPER – EU sponsored Consortium on Artificial Intelligence Program Manual BG entry 2017 Cellnovo System with Android Joint Development with TypeZero on Artificial Pancreas (License agreement) 2018 Cellnovo Handset replaced by Mobile phone terminal Artificial pancreas CE marking 2019 & beyond
CONT INUOUS GL UCOSE SE NSOR CONT R OL AL GOR IT HMPage 23
C o m p a r i s o n Ty p e Z e r o / M e d t r o n i c
- Founded in 2005, spin-off from UVA
- In clinical trials since 2011
- The most published Artificial Pancreas
SW
- Well-financed by the NIH
- CGM: G5 Dexcom
Type Zero, a Strong partner TypeZero inControl Medtronic PID-IFB
Paper Ly, Buckingham et al Diabetes Care, 2016 Ly, Buckingham et al DT&T, 2016 Control
24/7 – 85 days and nights Overnight only – 55 nights
Average BG Overnight
128 mg/dl 132 mg/dl
Overnight time within 70-180 mg/dl
90.3% 79.9%
Overnight time within 70-150 mg/dl
76% 66.4%
Overnight time below 70 mg/dl
1.4% 5.4%
24/7 time within 70- 180 mg/dl
78.6% n/a
24/7 time below 70 mg/dl
1.8% n/a
Agenda
1. A unique technology 2. A company well-placed on COGS 3. An aggressive commercial strategy 4. The next breakthrough: The Artificial Pancreas 5. Financials
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K e y F i n a n c i a l s o f t h e G r o u p - S a l e s
- 832 systems shipped in total since launch with 58 new systems in Q4 2017
- Production capacity of insulin cartridges constrained, ongoing ramp-up with Flex
Annual Quarterly – 3 months 2017 2016 Q4 2017 Q4 2016 Sales (in K Euros) 1,058 1,417 368.6 363.2 New systems sold (units) 203 405 58 109
At full capacity, Flex’s production line is able to produce 600,000 insulin cartridges per year
- A cash position of €13,0 million at Dec. 31, 2017
– It doesn’t include any drawdowns from the €20 million loan agreement made with the EIB in July 2017
Progress towards industrial production; sales still limited by capacity
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K e y F i n a n c i a l s o f t h e G r o u p – P & L
Simplified P&L in K€ – IFRS
H1 2017 H1 2016
Revenues Sales
473 753
Operating expenses
- /w Costs of production
(2,902) (3,377)
- /w Research and Development
(1,591) (1,068)
- /w Sales & Marketing
(1,457) (540)
- /w General & Administration
(2,284) (3,252)
Total Operating Expenses
(8,934) (8,237)
Other operating income and expenses
- Operating profit / (loss)
(8,461) (7,484)
Financial result
(694) (18)
Income tax
463 281
Net profit/(loss)
(8,691) (7,221)
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C e l l n o v o o n t h e M a r k e t
Shareholding structure as of July 12, 2017 Financial calendar
- Market listed on Euronext (Euronext Paris)
- Share price: €3.32 (Jan. 26, 2018)
- Market Cap: €56 million (Jan. 26, 2018)
- Number of shares: 16,746,617
Stock market information
Events Date 2017 FY results and 2018 Q1 sales April 12, 2018 Shareholders’ meeting May 24, 2018 2018 H1 sales and results July 26, 2018 2018 Q3 sales October 11, 2018
Board of Directors
- John Brooks, Chairman
- Sophie Baratte, CEO
- Julie Drapier, Aliad
- Marie Landel, Independent
- Sofia Loannidou, censor, Edmond de Rothschild I.P.
- Raj Parekh, Advent Venture Partners
- Holger Reithinger, Forbion Capital Partners
- Rémi Soula, Independent
- Raphael Wisniewski, Edmond de Rothschild I.P.
Forbion 11,4% EDRIP 11,0% Advent International 6,8% Air Liquide Investissement 3,0% Financière Arbevel 9,7% Others 58,1%